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Real-world Outcomes

In the past 15 years, PPD has designed, conducted, analyzed and
reported/managed more than 1,000 studies across all areas of medical affairs and
real-world outcomes. Our global services span the product life cycle.

R&D spend for medical affairs research is increasing, indicating the
importance of having a better understanding of and evidence for how products
will perform in a real-world setting to determine their true market value. PPD
can collaborate in the design, implementation, analysis and reporting of
scientifically robust and innovative research, providing real-world evidence of
a product's safety, effectiveness and economic value. PPD's real-world outcomes
capabilities include:

Epidemiology

Health economics and outcomes research

Observational research

Patient, product and disease registries

Post-approval safety studies

Pragmatic Phase IV trials

Patient-reported outcomes

Expanded access and compassionate use programs

Extended access programs

Interventional studies

Health Economics

Health economic research is conducted to generate evidence of the economic
benefit or impact of a health technology in a particular setting to optimize
patient access to health technologies. This optimization is achieved by
demonstrating to payers and health technology assessment agencies the economic
value of a new product, resulting in optimal formulary placement with a minimum
of utilization restrictions.

The types of economic analyses that might be conducted on a new health
technology may be any combination of the following:

Budget impact analysis

Cost of illness study

Cost-efficacy/effectiveness analysis

Cost-minimization analysis

Cost-utility analysis

HealthCore Alliance

PPD and HealthCore have established a health services and real-world outcomes
research partnership. Our clients can now benefit from PPD’s clinical trial
design, health economics and outcomes research and medical affairs research
services in addition to HealthCore’s strengths in innovative real-world research
designs and robust research-enabled electronic health care data environment.
This partnership generates evidence that will more quickly demonstrate how
products will perform and benefit patients in the real world, while covering
product research in pre- and post-approval settings. Together, we are setting
new standards for quality, cost and speed of real-world evidence research. The
information generated can facilitate decisions and speed products to market.

Patient-reported Outcomes

Patient-reported outcomes are a subset of a broader category of assessments —
clinical outcomes assessments (COA) — that may be carried out to understand the
broad impact of a new health technology.

A PRO is a measurement based on a report that comes from the patient (i.e.,
study subject) about the status of a patient’s health condition without
amendment or interpretation of the patient’s report by a clinician or anyone
else.

Typical PROs that are generated during a product development program
include:

Disease-specific, health-related quality of life

General health-related quality of life

Health utilities measurements

Patient preference and/or satisfaction

Symptom scores

The PRO research plan for a new product may be of prime strategic importance
to its commercial success, because they can serve as an important differentiator
over a competitor. A PRO strategy should be planned and implemented in the
earliest stages of product development.

The science includes objective clinical outcomes as well as provider- and
patient-reported outcomes. While public health experts have traditionally
focused on post-approval, population-oriented safety and effectiveness, the
biopharmaceutical industry recognizes the value of leveraging the science early
in the product development process.

PPD’s epidemiology and health outcomes experts are:

Engaged in product safety and health outcomes across the product life
cycle and risk management continuum

Focused on addressing safety and health outcomes holistically and
contributing to a product’s comprehensive benefit-risk profile

Unlike interventional studies, which are based on a single design,
epidemiologic (observational) studies vary in design and are unique in
execution. Because companies are often unsure how to answer critical
epidemiologic questions, PPD works closely with clients to first understand
their challenges and identify the optimal approach. PPD’s epidemiologists have
consulted on the design and successful execution of many types of studies. A
partial listing of these studies includes:

Subscribe to the Evidence Forum

An official publication of Evidera that addresses the scientific and strategic challenges of today’s health care environment and provides a forum for the exchange of thoughts and ideas focused on evidence and value.